BS EN ISO 10993-13:2010
$142.49
Biological evaluation of medical devices – Identification and quantification of degradation products from polymeric medical devices
| Published By | Publication Date | Number of Pages |
| BSI | 2010 | 28 |
This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.
This part of ISO 10993 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. This part of ISO 10993 considers only non-resorbable polymers. Similar but appropriately modified procedures may be applicable for resorbable polymers.
This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity.
NOTE An informative text discussing environmental stress cracking (ESC) of polymers is included as a potential aid to the design of degradation studies (see Annex B).
The biological activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, but should be evaluated according to the principles of ISO 10993-1, ISO 10993-16 and ISO 10993-17.
Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques are identified or given preference. No specific requirements for acceptable levels of degradation products are provided in this part of ISO 10993.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 11 | Scope Normative references Scope Normative references |
| 12 | Terms and definitions Degradation test methods General procedures Test design Sample preparation Terms and definitions Degradation test methods General procedures Test design Sample preparation |
| 13 | Initial material characterization Test solutions and apparatus Test solutions General Test solutions for hydrolytic degradation Test solutions for oxidative degradation Container Initial material characterization Test solutions and apparatus Test solutions General Test solutions for hydrolytic degradation Test solutions for oxidative degradation Container |
| 14 | Balance Drying apparatus Vacuum source Separation apparatus Number of test samples Shape and size of test samples Balance Drying apparatus Vacuum source Separation apparatus Number of test samples Shape and size of test samples |
| 15 | Mass/volume ratio Sample pre-treatment pH range Determination of the mass balance Final material characterization Accelerated degradation test Temperature Mass/volume ratio Sample pre-treatment pH range Determination of the mass balance Final material characterization Accelerated degradation test Temperature |
| 16 | Test periods Real-time degradation test in a simulated environment Temperature Test period Test procedures General Initial material characterization Accelerated degradation test Measurement of initial mass Test periods Real-time degradation test in a simulated environment Temperature Test period Test procedures General Initial material characterization Accelerated degradation test Measurement of initial mass |
| 17 | Separation of sample, debris and solution Separation by filtering Separation by centrifuging Analysis Determination of mass balance Final material characterization (sample and debris) Evaluation General Case 1 (No/No) Case 2 (No/Yes) Case 3 (Yes/No) Separation of sample, debris and solution Separation by filtering Separation by centrifuging Analysis Determination of mass balance Final material characterization (sample and debris) Evaluation General Case 1 (No/No) Case 2 (No/Yes) Case 3 (Yes/No) |
| 18 | Case 4 (Yes/Yes) Case 4 (Yes/Yes) |
| 19 | Real-time degradation test in a simulated environment Measurement of initial mass Separation of sample, debris and solution Separation by filtering Separation by centrifuging Analysis Determination of mass balance Final material characterization (sample and debris) Evaluation General Case 1 (No/No) Case 2 (No/Yes) Real-time degradation test in a simulated environment Measurement of initial mass Separation of sample, debris and solution Separation by filtering Separation by centrifuging Analysis Determination of mass balance Final material characterization (sample and debris) Evaluation General Case 1 (No/No) Case 2 (No/Yes) |
| 20 | Case 3 (Yes/No) Case 4 (Yes/Yes) Test report Case 3 (Yes/No) Case 4 (Yes/Yes) Test report |
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